Whether low-tech or high-tech, there are many exciting new frontiers in medicine. But how much of it will one-size-fits-all regulators and their corporate cronies allow to see the light of day?
In part 1 of our series, we discussed how Medicare is run by billing codes that often prevent some essential services such as accessing healthcare through phone and email (especially important in today’s technology-driven world).
In part 2, we reported on FDA’s plan to pre-approve medical and smartphone apps, which will make them impossibly expensive. Basically, a whole new frontier of medicine will be shut down for the convenience of government and big drug companies.
In part 3, we continue to highlight some major potential technological advances for medicine identified by leading health policy analyst John Goodman—advances that may be throttled by government regulation, especially government regulation contaminated by crony capitalism.
As a general rule, we at ANH are highlighting the gains to be made from low-tech medicine, based on food, supplements, and lifestyle. For example, we don’t understand why conventional doctors refuse to use garlic to treat food poisoning, even when conventional and potentially harmful antibiotics have totally failed to cure a patient.
But all of this—including the use of garlic—depends on excellent, cutting-edge science. And we aren’t at all opposed to sensible medical technology breakthroughs, especially when they are as basic as smartphone apps, and we don’t like the FDA throttling these any more than we like the FDA throttling natural medicine.
Here are some of the additional technologies that John Goodman has mentioned recently:
- Sensors—implantable or attachable devices that can monitor the conditions of diabetics, asthmatics, heart patients, and patients with numerous other chronic conditions—will allow patients and doctors to modify therapeutic regimens and tailor treatments to individual needs and responses.
- Genetic testing to see if a patient’s own genes indicate that she or he should take certain drugs or avoid other drugs, tailoring medical treatment to personal needs in a dramatic way.
These could be exciting advances—but they run afoul of government rules and regulations:
- To get paid—whether for implanting a sensor or for conducting a genetic test—there has to be a Medicare billing code. If the product or the test is new, getting Medicare to create a new billing code for it can take a long time and cost a significant amount of money.
- Even if there is already a billing code, Medicare must agree to pay for the service. In general, Medicare has not been willing to pay for genetic testing (except in screening for compatibility for kidney and bone marrow transplants), and it is certainly unwilling to do the level of genetic testing needed to do truly personalized medicine.
- Congress has imposed price controls on what Medicare can pay laboratories that conduct genetic testing. So the number and extent of the tests themselves will necessarily be limited.
- Clinical trials are time-consuming and expensive. But the bigger problem is that with personalized medicine, doctors are going to react to the information the sensor provides and change their therapy accordingly. As a result, every patient in the clinical trial could be treated differently—which defeats the whole purpose of a trial. Since random-controlled trials are the “gold standard,” RCTs will be kept, and personalized medicine will be jettisoned.
- Out-of-date and inflexible malpractice laws complicate matters because an electronic sensor can send the doctor a great deal of data at any time day or night. Some doctors worry that buried in the data could be information that the doctor doesn’t see. If a problem later develops, a lawyer might argue that he should have seen it. And that means many doctors simply won’t use sensors, just to be on the safe side.
As John Goodman also points out, the Patient Protection and Affordable Care Act, with its emphasis on pilot programs and demonstration projects, is supposed to promote “evidence-based care.” But in reality it requires standardization and a one-size-fits-all approach.
Dr. Richard N. Fogoros, a former professor of medicine and a longtime practitioner, researcher, and author in the fields of cardiology and cardiac electrophysiology, puts it this way: “The role of the doctor is now to relay expert-guided determinations of what is best for the herd down to the level of individual patient, and to do so in such a way that their patients do not realize that the doctor’s recommendations are population-based, and not tailored to their own needs.”
This is one brave new world that we do not need. But only by working together to reform government and the FDA can we prevent it.